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Neuroma Injections to Treat Restless Legs Syndrome - RCT

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Lowcountry Infectious Diseases.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656110
First Posted: April 10, 2008
Last Update Posted: March 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lowcountry Infectious Diseases
  Purpose
The purpose of this study is to determine whether, in a randomized, placebo-controlled trial, restless legs syndrome (RLS) can be caused by pinched and damaged foot nerves called neuromas.

Condition Intervention
Restless Legs Syndrome Drug: equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml Drug: Normal saline - 1ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome

Resource links provided by NLM:


Further study details as provided by Lowcountry Infectious Diseases:

Primary Outcome Measures:
  • International Restless Legs Rating Scale [ Time Frame: Weekly during the study and three weeks after treatment completion ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-T
Treatment Group
Drug: equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml
Bilateral 3rd/4th common digital nerve injections with neuroma treatment mixture given weekly for 3 weeks
Placebo Comparator: 2-P
Placebo comparator
Drug: Normal saline - 1ml
Bilateral 3rd/4th common digital nerve injections with normal saline given weekly for 3 weeks

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical symptoms (that fulfill the 4 essential clinical criteria for RLS) of at least 6 months duration with a current IRLS-rs score indicative of at least moderate severity (15 or greater)
  • Evidence of bilateral 3rd/4th interspace neuromas by both physical examination and ultrasound criteria at initial evaluation
  • Willingness and ability of patient to participate in initial weekly evaluation/neuroma treatment visits and subsequent periodic follow-up visits over a period of approximately 6-9 weeks.
  • Off dopaminergic drug treatment (ropinirole-"Requip" or pramipexole-"Mirapex") starting 2 weeks prior to the initial foot injections and for the duration of the study.

Exclusion Criteria:

  • Major foot deformity, previous major foot surgery, or previous neuroma injections
  • Known or suspected obstructive sleep apnea
  • Allergy to any of injection components (depo-medrol, lidocaine, marcaine, absolute alcohol)
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656110


Contacts
Contact: Ludwig A Lettau, MD 843-402-0227 lettaul@comcast.net
Contact: Lisa A Lettau, RN, BSN 843-813-2940 lettaul@comcast.net

Locations
United States, South Carolina
Southeastern Foot Specialists Recruiting
Charleston, South Carolina, United States, 29414
Contact: Charles J Gudas, DPM    843-852-9444    gudasturbo@bellsouth.net   
Sub-Investigator: Charles J Gudas, DPM         
Sponsors and Collaborators
Lowcountry Infectious Diseases
Investigators
Principal Investigator: Ludwig A Lettau, MD Lowcountry Infectious Diseases
  More Information

Publications:
Lettau LA, Gudas CJ. Bilateral Morton's neuromas as an etiology of restless legs syndrome. Journal of the South Carolina Medical Association 101: e341-e347, 2005

Responsible Party: Ludwig A. Lettau, M.D., Lowcountry Infectious Diseases
ClinicalTrials.gov Identifier: NCT00656110     History of Changes
Other Study ID Numbers: LID-RLS-RCT-01
(None)
First Submitted: April 6, 2008
First Posted: April 10, 2008
Last Update Posted: March 10, 2009
Last Verified: March 2009

Keywords provided by Lowcountry Infectious Diseases:
Restless legs syndrome
Morton's neuroma
Randomized controlled trial

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Lidocaine
Ethanol
Methylprednisolone acetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action